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NCT03897621 · ClinicalTrials.gov registry record · NA
The Effect of Tranexamic Acid on Blood Coagulation in Total Hip Arthroplasty Surgery
A NA study of Total Hip Arthroplasty and Tranexamic Acid, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT03897621: Completed NA study of Total Hip Arthroplasty and Tranexamic Acid, sponsored by Thomas Jefferson University.
NCT03897621 is a NA study of Total Hip Arthroplasty and Tranexamic Acid that has completed, run by Thomas Jefferson University. The registered enrollment target is 50 participants, below the 141-participant average among 12 other Total Hip Arthroplasty trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03897621, a NA study of Total Hip Arthroplasty and Tranexamic Acid, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Total hip arthroplasty (THA) is associated with blood loss ranging from 300 to 2000 mL. Tranexamic acid (TXA) is frequently administered prophylactically during this procedure to reduce blood loss by inhibiting fibrinolysis or by stopping naturally occurring clot resolution. TXA is employed currently based on a surgeon's preference. The objective of this study is to quantitate the degree of fibrinolysis using rotational thromboelastometry (ROTEM) and investigate the role of TXA prophylaxis on blood loss in patients undergoing THA in a double-blind fashion. Our hypothesis is that fibrinolysis is minimal at most and TXA prophylaxis is not necessary during THA. All patients, whether they receive TXA or normal saline, will not be at risk, as at this time no data exists to determine which approach is safer or more effective. This is the first study to compare TXA vs. placebo in a double-blinded, randomized controlled trial.
Primary Outcome
Fibrinolysis based on ROTEM parameter, defined as ML (maxium lysis) \>15%
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tranexamic Acid
Study Locations (1)
Pennsylvania
- Thomas Jefferson University Hospital - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2019-05-20 |
| Est. Completion | 2022-12-20 |
| Phase | NA |
What the finished NCT03897621 record still lists
NCT03897621 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 141-participant average among 12 other Total Hip Arthroplasty trials with a reported enrollment target (65% lower).
The record links to 5 conditions, with Total Hip Arthroplasty appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03897621 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03897621 about?
NCT03897621 is a clinical study titled "The Effect of Tranexamic Acid on Blood Coagulation in Total Hip Arthroplasty Surgery". Total hip arthroplasty (THA) is associated with blood loss ranging from 300 to 2000 mL. Tranexamic acid (TXA) is frequently administered prophylactically during this procedure to reduce blood loss by inhibiting fibrinolysis or by stopping naturally occurring clot resolution. TXA is employed currentl...
What is the current status of trial NCT03897621?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2019-05-20. Estimated completion is 2022-12-20.
What conditions does trial NCT03897621 study?
This clinical trial studies the following conditions: Total Hip Arthroplasty, Tranexamic Acid, Rotational Thromboelastometry, Fibrinolysis; Hemorrhage, Coagulation; Intravascular.
What interventions are being tested in trial NCT03897621?
The interventions under investigation include: Placebo (DRUG), Tranexamic Acid (DRUG).
Who is sponsoring clinical trial NCT03897621?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03897621 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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